Actively Recruiting
A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-05-05
216
Participants Needed
21
Research Sites
126 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead Sponsor
S
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy
CONDITIONS
Official Title
A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed primary membranous nephropathy by kidney biopsy
- Kidney function (eGFR) of at least 45 mL/min/1.73 m2
- Stable doses of ACE inhibitors, angiotensin II receptor blockers, SGLT2 inhibitors, or endothelin inhibitors for at least 4 weeks before randomization
- Elevated 24-hour urinary protein as defined by the study
- Laboratory test results meeting study standards during screening
- Informed consent given voluntarily
- Able to follow the study protocol as judged by the investigator
You will not qualify if you...
- Secondary membranous nephropathy or presence of crescent bodies in pathology
- Previous resistance to CD20 monoclonal antibody or cyclosporine
- Prior treatment for membranous nephropathy
- Presence of other prescribed diseases
- Severe allergic reactions to humanized monoclonal antibodies or allergies to cyclosporine or B007 components
- Live vaccination, major surgery, or participation in other trials within 28 days before study drug
- Positive hepatitis B surface antigen or hepatitis C virus antibody
- History or presence of immunodeficiency diseases
- History of tuberculosis or anti-tuberculosis treatment
- CD4+ T lymphocyte count below 400 cells/μL
- Pregnant or breastfeeding women; women of childbearing potential not using contraception
- Male subjects not using barrier contraception or other contraceptive methods for themselves or partners during and 12 months after treatment
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Beijing Tsinghua Changgung Hospital
Beijing, China
Actively Recruiting
2
Peking university first hospital
Beijing, China
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3
The Second Norman Bethune Hospital of Jilin University
Changchun, China
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4
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
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5
Zhujiang Hospital of Southern Medical University
Guangzhou, China
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6
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, China
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7
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
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8
Shandong Provincial Hospital
Jinan, China
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9
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
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10
Affiliated Hospital of Nantong University
Nantong, China
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11
The Affiliated Hospital of Qingdao University
Qingdao, China
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12
Northern Theater Command General Hospital
Shenyang, China
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13
Shengjing Hospital affiliated to China Medical University
Shenyang, China
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14
Peking University Shenzhen Hospital
Shenzhen, China
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15
Renmin Hospital of Wuhan University
Wuhan, China
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16
Wuxi People's Hospital
Wuxi, China
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17
Xi'an Daxing Hospital
Xi'an, China
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18
The Second Affiliated Hospital of Xingtai Medical college
Xingtai, China
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19
Northern Jiangsu People's Hospital
Yangzhou, China
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20
Yantai Yuhuangding Hospital
Yantai, China
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21
The First People's Hospital of Zigong
Zigong, China
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Research Team
M
Minghui Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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